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A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers

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ClinicalTrials.gov Identifier: NCT01478438
Recruitment Status : Active, not recruiting
First Posted : November 23, 2011
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Novian Health Inc.

Tracking Information
First Submitted Date  ICMJE November 17, 2011
First Posted Date  ICMJE November 23, 2011
Last Update Posted Date March 3, 2021
Study Start Date  ICMJE April 2012
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2011)
Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial [ Time Frame: one month end point ]
Evaluate the rate of complete tumor ablation by Novilase ILT of small breast cancers and characterize the correlation of imaging (MR, US, x-ray) in detecting residual post ablation with histopathology of the excised specimen. An individual patient will be considered to have a complete ablation if the pathology results post excision demonstrates that no visible gross residual tumor is present.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2011)
To gain experience with the cosmetic outcome and rate of recovery tools [ Time Frame: One month end point ]
Evaluate satisfaction, utilizing the European Organization for Research and Treatment of Cancer Breast Cancer Specific Quality of Life Questionnaire (EORTC QLQ-BR23) survey and cosmetic outcome utilizing the physician-reported Four-Point Scoring System of Breast Cosmesis.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
Official Title  ICMJE A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
Brief Summary This study will determine the rate of complete tumor ablation of small breast cancers (≤ 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT ablation as correlated to histopathology from the post-ablation excision.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malignant Tumor
Intervention  ICMJE Device: Novilase Interstitial Laser Therapy
Image guided Interstitial Laser Ablation of breast tumors
Other Name: Novilase®
Study Arms  ICMJE Experimental: Treat and Excise
All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation.
Intervention: Device: Novilase Interstitial Laser Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2011)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2021
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Females 18 to 80 years of age
  • Tumor is well visualized through x-ray mammography or ultrasound imaging and amenable to image guidance therapy (a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins
  • obscured by other structures or artifacts on the images)
  • Tumor must be well visualized (as defined above) on MRI
  • Definitive pathologic diagnosis by needle core biopsy
  • Unifocal malignant tumor that does not exceed 20mm in diameter and measures at least 5mm away from the skin and chest wall
  • Cluster of microcalcifications that do not exceed 10 mm in diameter and measures at least 5mm away from the skin and chest wall
  • Subjects with or without palpable lymph nodes
  • Subjects with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
  • Subjects with less than 25% intraductal component
  • Subject has no clinically significant co-morbidities (i.e. chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy. Subject has given written informed consent
  • Subject agrees to comply with follow up visits

Exclusion Criteria:

  • Subjects younger than 18 years of age
  • Pregnant or breast-feeding women
  • Tumors poorly visualized by x-ray mammography or ultrasound imaging
  • Women who are morbidly obese (>300 lbs)
  • Acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) <30ml/min/1.73 sq.meters)
  • Moderate to end-stage kidney disease and a history of severe asthma or allergies
  • Tumors measuring greater than 20mm in diameter
  • Subjects with advanced stage breast cancer
  • Subjects with prior history of cancer in the ILT treated breast
  • Subjects with recurrent breast cancer
  • Subjects with lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phylloides tumor, or Paget's disease
  • Subjects with benign vascular tumor
  • Subjects with benign lesions such as fibroadenoma, atypical ductal hyperplasia, sclerosing adenosis, Papilloma, fibrocystic disease of breast
  • Subjects with DCIS with microinvasion
  • Subjects with a cluster of microcalcifications whose diameter is larger than 10 mm.
  • Subjects with extensive intraductal component and other characteristics not well visualized by imaging studies
  • Subjects who are BRCA positive.
  • Inability to lie prone or supine for one hour
  • Currently participating or enrolled in another investigational treatment, device or drug study through follow up
  • Undergoing concurrent neoadjuvant therapies for breast cancer
  • Cardiac pacemaker or other metallic implants which would prevent patient from safely undergoing MRI scan
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01478438
Other Study ID Numbers  ICMJE BR-002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novian Health Inc.
Study Sponsor  ICMJE Novian Health Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Barbara Schwartzberg, MD Rose Medical Center - Rose Breast Center
Principal Investigator: Michael Shere, M.D. North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
PRS Account Novian Health Inc.
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP